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NCT02823574 · OUTCOME

Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to death. Approximately 63 Months

What was measured

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Analysis population: All Randomized Participants - Platinum Eligible Subgroup

Groups in this outcome

Treatment A - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Treatment B - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup123
Treatment B - Platinum Eligible Subgroup61

Reported measurements

Positive

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup35
Treatment B - Platinum Eligible Subgroup17
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup16.66Not reported8.5428.06Not reported
Treatment B - Platinum Eligible Subgroup33.74Not reported12.91NAInsufficient number of events to calculate upper limit number.
Negative

Analysis denominator · Participants

GroupSource count
Treatment A - Platinum Eligible Subgroup88
Treatment B - Platinum Eligible Subgroup44
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A - Platinum Eligible Subgroup7.79Not reported5.0612.39Not reported
Treatment B - Platinum Eligible Subgroup9.46Not reported5.3214.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.54
        upper Limit
        28.06
        value
        16.66
      2. comment
        Insufficient number of events to calculate upper limit number.
        group Id
        OG001
        lower Limit
        12.91
        upper Limit
        NA
        value
        33.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.06
        upper Limit
        12.39
        value
        7.79
      2. group Id
        OG001
        lower Limit
        5.32
        upper Limit
        14.00
        value
        9.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        44
      units
      Participants
    title
    Negative
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      61
    units
    Participants
description
Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    OG000
    title
    Treatment A - Platinum Eligible Subgroup
  2. description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    OG001
    title
    Treatment B - Platinum Eligible Subgroup
param Type
MEDIAN
population Description
All Randomized Participants - Platinum Eligible Subgroup
reporting Status
POSTED
time Frame
From randomization to death. Approximately 63 Months
title
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice